Roche’s Alecensa Gains FDA Approval for Postsurgical Early Lung Cancer Treatment

1. Roche has received FDA approval for Alecensa as a treatment for early lung cancer in a postsurgical setting.
2. This approval is a significant milestone for Roche, as the company aims to broaden the use of Alecensa in lung cancer treatment.
3. Meanwhile, Roche's Genentech unit has withdrawn Gavreto (another cancer drug) from the treatment of advanced RET-mutant medullary thyroid cancer due to unfeasibility of the confirmatory phase 3 trial, AcceleRET-MTC.
4. Gavreto maintains its approval for RET fusion-positive thyroid cancer, with the FDA's postmarketing requirements calling for additional data from patients in the ARROW trial and the basket TAPISTRY trial.
5. Roche is also investigating Gavreto in a phase 3 trial, AcceleRET-Lung, for RET fusion-positive non-small cell lung cancer.
6. The FDA has increased scrutiny on accelerated approvals that don't meet confirmatory trial requirements, which has led to market withdrawals of certain PD-1/L1 inhibitors, PI3K inhibitors, PARP inhibitors, and other medications.

These developments highlight Roche's focus on expanding the use of Alecensa in lung cancer treatment while navigating the challenges of confirmatory trials and regulatory requirements for other cancer drugs like Gavreto.